Systems and methods for suturing tissue

ABSTRACT

A device for suturing tissue includes a handle including a housing and a suturing needle for advancing a suture through the tissue. The device also includes a first needle gripper that is configured to both grasp and release the suturing needle. A second needle gripper is also configured to both grasp and release the suturing needle. An actuator is coupled to the housing and is operatively coupled to: (a) a first linkage that pivots the second gripping gripper between a fully extended position and a retracted position relative to the housing; and (b) a second linkage that is operatively coupled to the first and second needle grippers and configured to alter a state of each of the first and second needle grippers. The second linkage can include a one-way clutch.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 14/715,081, filed May 18, 2015, which claims the benefit of andpriority to U.S. patent application Ser. No. 61/994,890, filed May 17,2014 and U.S. patent application Ser. No. 62/149,532, filed Apr. 18,2015, each of which is hereby incorporated by reference in its entirety.

BACKGROUND

Needles and suture are used throughout the healthcare industry forindications such as wound and incision closure, securing catheters, andaffixing implantable meshes, annuloplasty rings, and other medicalapparatus. These sutures are used on the surface of the patient's skinas well as through laparoscopic, endoscopic, and surgical procedures.Because needles represent injury and illness risks to the user, there isa need to make needle usage safer without sacrificing ease of use,performance, and cost. A medical device that can be used to safelysuture the tissue of a patient will be valuable to physicians, surgeons,nurses, physician assistants, military personnel, and other clinical andnon-clinical users of suture.

SUMMARY

In one embodiment, a device for suturing tissue according to the presentinvention includes a handle including a housing having a distal end andan opposite proximal end and a suturing needle for advancing a suturethrough the tissue. The suturing needle has a first pointed end and anopposite second end. The device also includes a first needle gripperthat is coupled to the housing and configured to both grasp and releasethe suturing needle. A second needle gripper is also coupled to thehousing. The second needle gripper is configured to both grasp andrelease the suturing needle.

An actuator is coupled to the housing and is operatively coupled to: (a)a first linkage that pivots the second gripping gripper between a fullyextended position and a retracted position relative to the housing; and(b) a second linkage that is operatively coupled to the first and secondneedle grippers and configured to alter a state of each of the first andsecond needle grippers to permit each respective needle gripper toeither: (a) receive and grasp the suturing needle or (b) release thesuturing needle. In accordance with one embodiment, the second linkageincludes a one-way clutch that is operatively coupled to the actuatorand is configured to synchronously alter the states of the first andsecond needle grippers to permit each respective needle gripper toeither: (a) receive and grasp the suturing needle or (b) release thesuturing needle.

The first linkage can include a plurality of gears that operativelycouple the actuator to the second needle gripper such that motion of theactuator is translated into the second needle gripper rotating about afirst pivot point between the fully extended position and a retractedpositions. In addition, the second linkage can include an energy storagemechanism that is configured to store energy during an inward stroke ofthe actuator and release the stored energy during one stage of anoutstroke of the actuator, whereby the release of the stored energycauses the states of the first and second needle grippers to be altered.

The device preferably includes additional features, such as a safetymechanism that shields the needle and a suture cutter.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1a is a side elevation view of a suturing device in a rest(packaged) position;

FIG. 1b is a side elevation view of the suturing device with a movablegripping mechanism in a retracted position after completion of an inwardstroke of an actuator to expose a needle;

FIG. 1c is a side elevation view of the suturing device pivoted suchthat the needle penetrates and exits tissue;

FIG. 1d is a side elevation view of the suturing device after themovable gripping mechanism returns to its extended state and grips theneedle upon completion of an outstroke of the actuator;

FIG. 1e is a side elevation view of the suturing device after a secondinward stroke of the actuator is completed resulting in the needle beingextracted from the tissue;

FIG. 1f is a side elevation view of the suturing device after anoutstroke of the actuator is completed resulting in the needle beingreturned to the initial position;

FIG. 1g is a side elevation view of a suturing device according to oneembodiment showing one type of safety mechanism and needle grippers;

FIG. 2 is a side elevation view of one embodiment of the suturing deviceshowing a gripping mechanism according to one embodiment;

FIG. 3 is a side elevation view of a first side of the suturing devicewith one part of the housing removed to show the internal components ofthe actuator;

FIG. 4 is a close-up of a windup mechanism that is part of the actuator;

FIG. 5 is another close-up of the windup mechanism along with acrankshaft assembly and a locking mechanism in the form of a pawl;

FIG. 6 is a perspective view of a crankshaft ratchet and the pawl in anengaged state;

FIG. 7 is a cross-sectional view of the crankshaft ratchet and pawl inthe engaged state;

FIG. 8 is a cross-sectional view of the combined crankshaft ratchet andwindup ratchet showing an anti-reverse feature of the crankshaftratchet;

FIG. 9 is a cross-sectional view of a mechanism to stop rotation of acrankshaft after it has rotated a predetermined number of degrees;

FIG. 10 is a perspective view of a first linkage (gear train) thatconnects the actuator to the second needle gripper;

FIG. 11 is a perspective view of the distal end of the device showing asafety mechanism and the first and second needle grippers;

FIG. 12 is a perspective view of one needle gripper;

FIG. 13 is a cross-sectional view of one needle gripper;

FIG. 14 is a perspective view of an alternate gripper design;

FIGS. 15-18 are various views of one exemplary safety shield mechanism;

FIGS. 19-26 are various views of an alternative needle gripperconstruction;

FIGS. 27-28 are various views of another alternative needle gripperconstruction;

FIGS. 29-30 are various views of yet another alternative needle gripperconstruction; and

FIG. 31 is a cross-sectional view of an alternative suture cutter.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

Disclosed herein are device concepts and methods for safely suturingtissue, skin, muscle, ligament, tendon and similar structures throughoutthe entire body. Healthcare workers need a safe method and device forclosing wounds and incisions, approximating tissue, securing meshes andannuloplasty rings, securing catheters to a patient, and relatedfunctions. The current procedure typically consists of a user graspingan unprotected needle and suture with hemostats, a needle driver,forceps, or suturing device and then piercing the patient's tissue byutilizing hand, wrist, and device movements. In this scenario, theneedle point is exposed to the user before, during, and after theprocedure and provides risk for accidental needle stick injuries (NSI)to the user and procedural staff. These NSIs can transmit bloodbornepathogens such as hepatitis and HIV to the user and others from thepatient and potentially cause illness or death. Users that are injuredin this manner are required to report the injury, undergo diagnostictests and begin receiving prophylactic treatment. They may also berequired to take a leave of absence from work or continue indefinitelywith a prescribed drug regimen.

A device according to one exemplary embodiment is a compact,light-weight handheld device that includes a needle and suture assembly,a mechanism for gripping and releasing the needle and suture assembly (a“needle transfer mechanism” or “needle shuttle mechanism”), safelycapturing the needle assembly upon exit from the patient's tissue, andreturning the needle to a position such that the process of deliveringadditional sutures to the patient can be repeated. The device of thepresent invention accommodates the right or left-handed user, restscomfortably in the user's hand, allows sufficient visualization of theprocedure site, and permits the user to either control penetration depthof the needle or default to a device-determined depth. The presentdevice permits the user to utilize a wrist-rotation (pivoting) suturedelivery technique that is familiar to a user based on experience withother surgical techniques.

In a preferred embodiment, the device has the following definitiveadvantages over current art: Safety: The user cannot contact the pointof the needle and is able to avoid accidental NSIs and the human andfinancial costs associated with those accidents. Performance: The deviceallows the user to reproduce the needle delivery motion that iscurrently used by healthcare workers. This improves the accuracy andintegrity of the securement and reduces the trauma to the patient. Size:The device is sized and oriented for easy access to crowded and narrowregions of the patient's body such as the neck; Ease of Use: The devicecan be generally operated with one hand, by right-handed and left handedusers, and multiple sutures are able to be secured to the patientthrough a minimal series of steps. Cost: The device is designed as asingle use device that is economical and easy to manufacture.Versatility: The device is suitable for use within a hospitalenvironment and any first aid setting. It can be utilized to securenearly every type of catheter and to close wounds. In addition, it maybe packaged within catheter and medical accessory sets or as astand-alone device.

In one exemplary embodiment, the needle within this device can bereturned to its starting point after it crosses the patient's tissue sothat the device can be used to repeat the needle delivery processmultiple times. At the conclusion of the process, the needle is safelyretained by a mechanism within the device, which can then be safelydisposed. In this embodiment, safety features are incorporated into thedevice such that the user cannot come into contact with the needlebefore, during, and after the procedure. In addition, an integral cutteris incorporated into the device in order that the suture can be cut bythe user without the need for scissors or a scalpel. At the conclusionof each suture delivery, the safety features are automatically engagedand needle is safely shielded from the user. Additional elements withinthis embodiment include an integral cutter in order that the suture canbe cut or trimmed by the user without the need for a separate scissorsor scalpel.

Although it is contemplated as a single-use device, it is understoodthat slight alterations can be made to the design and materials thatwould allow said device to be resterilized, reloaded with an additionalneedle and suture, and reused. It may be further contemplated that thedistally mounted needle has the ability to rotate relative to the handleand replicate the manual needle-driving motion of crossing tissue thatis currently used in and outside the clinic. This is particularly usefulin laparoscopic, endoscopic, and surgical procedures when the user'snatural range of motion is compromised.

Looking again at the primary embodiment, the handle, which is comprisedof one or more components such as a housing, actuator, and buttons, maybe molded, cast or extruded from a variety of materials including butnot limited to polymers or metals. Examples of polymers suitable forfabricating the handle are thermoplastic and thermosetting materialssuch as polystyrene, acrylic, polycarbonate, polyamide, polyester,polyetherimide, polysulfone, polylactic acid, polyvinylchloride,polyolefins, polyurethane, fluoropolymers, and copolymers and alloysthereof. These materials may be filled with glass or other usefulreinforcing agents in order to enhance their mechanical properties.Suitable metals come from but are not limited to a group includingtitanium alloys and stainless steel. The selected materials must meetphysical and mechanical performance requirements and be able towithstand sterilization methods employed within the medical deviceindustry such as ethylene oxide or gamma irradiation. The handle designmay be constructed to be linear and longitudinal, non-planar, angled,arcuate or a combination of these conformations.

The needle assembly generally consists of a suturing needle and a sutureattached thereto. The suturing needle includes a distal pointed endsuitable for piercing and crossing tissue and a blunt proximal endsuitable for affixing a suture, and a body between the distal andproximal ends. The suturing needle can be fabricated in a variety ofconfigurations from straight to curved and be monolithic or of amulti-part construction. The outer diameters of the needles can be roundor non-round, tapered, or possesses features that assist in advancingand gripping the needle, i.e., flats, ribs, corners. Longitudinal ribsor recessions or other features found on the outer diameter of theneedle may provide additional rigidity and enhance the needle's abilityto effectively cross tissue. Needles are commonly made from stainlesssteel and related alloys but can be made from other metals, polymers andceramic materials that are sufficiently rigid, capable of possessing andsustaining a functionally sharp distal point, and able to attach tosuture. Traditionally, sutures are affixed to the proximal end of metalneedles by swaging, crimping, knotting and adhesives. Suture attachmentcan also be configured such that the suture is affixed to the otherregions of the needle, yet not the proximal terminus. This designvariant provides additional freedom for suture management and grippingthe needle in the device handle. In this configuration, attachment ofthe suture can be made by swaging, crimping, knotting, adhesives, etc.Coatings on the needle serve to enhance the lubricity of the needle andreduce tissue penetration forces.

The suture is the thread-like material that is used to treat internaland external wounds and incisions and to secure catheters or othercomponents to patients. It comes in a variety of diameters, textures,forms, i.e., single strand or braided, and materials depending upon thedesired properties and intended application. Sutures can be absorbable,i.e., collagen, polyglactin, polydioxanone, polyglycolide-lactidecopolymers, or non-absorbable, i.e., silk, nylon, polyester,polypropylene, stainless steel. They can be treated with antimicrobial,bioabsorbable, hydrophilic or other functional additives. In addition,they can have surface features, e.g., barbs, that permit the suture tobe drawn smoothly through tissue in one direction but snag the tissuewhen pulled in the opposite direction. This is advantageous when theuser wants to temporarily or permanently approximate tissue without theneed to tie a traditional knot.

The interfaces between the handle and the suturing needle/suture aregenerally referred to as the mechanisms or assemblies. These mechanismsserve to grasp, release, and shuttle the needle by manipulations to thehandle by the user or by otherwise manipulating the device to cause theneedle transfer. As will be appreciated from the detailed descriptionbelow, there are a number of mechanical mechanisms that can be used toproduce the desired movement of the suturing needle and morespecifically, produce a reciprocal needle transfer action in which thesuturing needle is initially held in one position within the mechanismand is then caused to be moved to another position within the mechanismto effectuate the suture needle passing into and through the tissue andthen being subsequently extracted from the tissue. Further, afterextraction, the mechanism is preferably designed to pass the suturingneedle back from the needle capture/extraction position to the initialposition at which the entire process can be repeated. Thus, onemechanism can be thought of as being a mechanism for cycling thesuturing needle between different positions that result in the desiredsuturing action.

In addition, as used herein, the term “linkage” refers broadly to one ormore parts that serve to link one part to another part. For example andas described herein, the actuator of the device is operatively connectedto a number of other parts, assemblies or mechanisms by means of one ormore linkages as set forth in greater detail herein.

It will thus be appreciated that a variety of mechanisms that are ableto grasp, release, and shuttle the needle can be used. The mechanismsinclude but are not limited to rack and pinion, gearing, cams, ramps,screw bodies, springs, multiple-point gripping structures, i.e.,3-point, collets, drive belts, and rigid and flexible push rods to namea few. In instances, the suturing needle can comprise physical featuresthat correspond to engagement features found within these mechanisms inorder, for example, to increase grip strength. Some examples of thesefeatures are indentations, serrations, projections, faces, flats,undercuts, rings, and ports.

Moreover, the present device preferably includes a safety shieldmechanism, which protects the user from the needle point before, during,and after the suturing procedure. The safety shield mechanism can existin numerous forms in that any number of different mechanicalarrangements can be used to accomplish the intended function. The safetyshield mechanism can comprise single or multiple components, be biasedto a safety-mode position and/or be user actuated, and/or havereversible or irreversible lockout features. The safety shield mechanismcan be configured, for example, as a slideable or rotatable cover, or asdeflectable wing-like shields that obstruct user access to the needlepoint. Similar to the handle described above, the safety shieldmechanism cans be made from a wide range of thermoplastics andthermosetting polymers; however, a transparent polymer may be moredesired as it would provide the user with greater visibility of theneedle and suturing site. Furthermore, the safety shield mechanism canbe manufactured from metals, such as stainless steel, titanium, andtitanium alloys including nickel-titanium, and configured as awire-form, mesh, grid, or strut. A spring or other force-resilientcomponents can be incorporated in order to bias the safety apparatusinto a safe position or to actuate multiple components that comprise thesafety apparatus.

Referring to the lockout feature above, it will prevent the user fromaccidentally exposing the needle and obtaining an NSI. The lockoutgenerally takes the form of a user-actuated button, lever, slide, orother similar means and a connecting element that couples the actuationmeans and the safety apparatus. The button causes the connecting elementto lock and unlock the apparatus in a variety of ways. Examples of thesemeans include tongue and groove, intermeshing gears, friction andinterference fits, inclined planes, cantilever, and screws. In each ofthese methods, the connecting element restricts the movement of theapparatus, and therefore, the exposure of the needle until the useractuates the button to release the apparatus.

Finally, a suture cutter is preferably located within the device handleso that the user can trim knotted sutures and suture strands to length.One exemplary cutter can be a dynamic shearing apparatus, i.e., scissorsor slideable blade(s), that requires the user to press or slide a buttonor manipulate an actuator having a different form, such as a knob orlever, in order to actuate the blade to cut the suture. To this end, thesuture(s) can be positioned in a notch, slot, or hole located on thehandle, and the actuation of the sharpened blade would cut thesuture(s). Upon cutting the suture, a spring or similar biasingcomponent would return the blade to its original position such that thecutting process can be repeated. The blade may traverse the suturecutting region with a linear, arcuate, or combination of these motions.Alternatively, the cutter can be a simple apparatus such as a staticcutting blade located in a narrowing, crevice-like feature on thehandle. In this configuration, the suture could be drawn across thesharp edge of the blade in order to cut it. Typical materials that areuseful as cutting blades are stainless steel, carbon steel, andgemstones, such as diamond. For safety purposes, the user does not havedirect access to the cutting blade; only suture is able to reach theblade via the suture cutter notch or hole. Beyond the safety advantage,the integral cutter would reduce or eliminate the need for the user toprovide a separate pair of scissors for cutting or trimming sutureduring the procedure.

It will be appreciated that the above-described structures constituteexemplary parts of one suturing device according to the presentinvention and each of these structures is described in greater detailbelow. The foregoing discussion is thus a brief summary of suitableparts that can be present within the present suturing device; however,they are not to be considered to be limiting of the scope of the presentinvention. The make-up and operation of various exemplary suturingdevices in accordance with the present invention are now described.

Referring to FIGS. 1a-1f , a suturing device 100 in accordance with afirst embodiment includes a housing 110 that contains a number of theworking components and allows a user to easily hold and use the suturingdevice 100. For example and as shown in the illustrated embodiment, thehousing 110 can be in the form of an elongated handle that is formed ofa first part 111 and a second part 114. The first and second parts 112,114 are complementary to one another and include a means for attachingthe two parts 112, 114 together to form an assembled handle 110 that canbe easily grasped and manipulated by the user. For example, the firstand second parts 112, 114 can be attached to one another by a mechanicalattachment, such as by using fasteners (e.g., screws, bolts, etc.), byestablishing a snap-fit between the two parts, or by another technique.The handle 110 not only houses many of the working components but alsoprovides a means for the user to grasp the device 100 but alsomanipulate it in such a way to cause a needle 101 to be advanced intoand through the tissue 10 and then exit the tissue 10.

Each of the first and second parts 112, 114 is generally hollow (e.g., ahollow shell) and therefore, when the two handle parts 112, 114 areattached to one another, they define a hollow interior handle space thatreceives and holds many of the working components of the device 100 aswill be appreciated below. The first part 112 is an elongated handlepart defined by a proximal end (upper end) 116 and a distal end (bottomend) 118 and similarly, the second part 114 is an elongated handle partthat is defined by a proximal end (upper end) 117 and a distal end(bottom end) 119. The handle 110 can include ergonomic grippingregions/surfaces 109 suitable for both left and right-handed users tofacilitate grasping of the device 100. As shown, these gripping regions109 can be in the form of locally recessed and contoured portions of thehandle 110 that locate and permit a user's thumb/fingers to grasp theexterior of the device 100. The gripping regions 109 can alternativelybe defined by a modified exterior surface of the housing parts 112, 114within local handle sections that allow the user to more easily graspthe handle. For example, the exterior surface of one or both of thehandle parts 112, 114 can be a rough surface defined by surfacefeatures, such as a plurality of raised bumps or the like or can even bedefined by a material that is different than the material of the handleand is applied thereto (e.g., a gripping surface member applied to thehandle 110 by means of an adhesive or over-molding process or othersuitable process). Additional examples of surface gripping featuresinclude but are not limited to loops, hooks and rings.

As shown in the figures and described in detail herein, the suturingdevice 100 is configured to move a curved suturing needle 101 in acontrolled manner such that the suturing needle 101 is advanced into andthrough target tissue 10 and is then extracted from the tissue 10 tocomplete one suturing action and allow the user to tie off the sutureelement 102 itself. As mentioned herein, any number of different typesof suturing needles 101 can be used with the device. In general, thesuturing needle 101 includes a sharp distal end 103 for penetrating thetissue 10 and an opposite proximal end 104, which is typically a bluntend.

The device 100 also includes an actuator assembly 125 that is used tooperate the device and to effectuate the controlled movement (shuttleaction) of the suturing needle 101 and cause the suturing needle 101 tobe driven into and then extracted from the tissue 10. The actuatorassembly 125 includes an actuator body 126 that is accessible to theuser and is manipulated by the user to cause controlled movement of thesuturing needle 101. In the illustrated embodiment, the actuator body126 extends from the side of the handle 110 and is accessible by theuser. The actuator body 126 is operatively coupled to other parts of theactuator assembly 125 to cause the desired controlled movement asdescribed herein below and in particular, causes needle transfer toeffectuate the suturing action.

It will be appreciated that the illustrated actuator assembly 125 ismerely one exemplary type of actuator that can be used in the presentdevice to cause controlled movement of the suturing needle 101 and thereare a number of other actuator assemblies that can be used for causingthe needle 101 to be transferred (shuttled) in the manner describedherein. For example, while the actuator body 126 is pivotably rotated bythe user (e.g., as by pressing the body 126 into the hollow interior ofthe handle 110), other actuators suitable for use in the presentinvention can be activated by other techniques, such as pressing abutton, rotating an actuator element, etc. In addition, the actuatorbody 126 is not limited to traveling within the hollow interior of thehandle 110 but instead can travel long an outer surface of the handle110. Thus, the actuator could be mounted on any number of the availablesurfaces on the device 100.

The needle transfer mechanism is comprised of two primarysub-mechanisms: a first gripping mechanism (first needle gripper orfixed clamp) 200 and a second gripping mechanism (second needle gripperor catch arm) 210. The first gripping mechanism 200 firmly holds theneedle 101 and allows the user to penetrate tissue 10 and also toreceive the needle 101 from the second gripping mechanism 210 in orderto deliver additional sutures. The second gripping mechanism 210 servesto cover the sharp distal 103 end of the needle 101 while the device 100is in its packaged and reset condition, and the second grippingmechanism 210 also serves to actively extract the needle 101 from tissue10. The first gripping mechanism 200 is generally stationary within thehandle 110, while the second gripping mechanism 210 is generally movablerelative to the first gripping mechanism 200 and handle 110 to allow fortransfer (shuttling) of the needle 101 between the first and secondgripping mechanism 200, 210.

In the illustrated embodiment, the actuator body 126 extends from oneside of the handle body and is operatively connected to a needletransfer mechanism, which as mentioned herein, is designed tocontrollably move the needle 101 from one operating position to anotheroperating position and more specifically, to transfer the suturingneedle 101 from one needle gripping mechanism 200, 210 to the othermechanism 200, 210 to allow the suturing needle 101 to be extracted fromthe tissue 10 once it passes therethrough.

Continuing with FIGS. 1a-1f , the general operation of the device 100 isdepicted. Please note that not all features, i.e., suture cutters, depthcontrollers, safety apparatus, are shown in these figures. They arepresented in separate figures and described in detail with reference tothese other figures.

FIG. 1a shows the device in its packaged condition (initial restposition) with the first gripping mechanism 200 having a firm grasp ofthe blunt end of the needle 101. The needle point 103 is covered by thesecond gripping mechanism 210 and is exposed when the user depresses theactuator 125 (inward stroke of the actuator 125 which results in asweeping, non-linear motion of the actuator). The user can now penetratethe patient's tissue 10 with the needle 101 by orienting the handle 110such that the needle point 103 is generally perpendicular to the tissue10 as seen in FIG. 1b . Once the needle 101 is properly oriented, theuser rotates his wrist such that the needle 101 penetrates and exits thetissue 10 as presented in FIG. 1c . When the needle 101 exits the tissue10, a safety guard (not shown but illustrated in other figures)surrounds the needle point 103 and protects the user from injury. FIG.1d depicts the second gripping mechanism 210 capturing the pointed end103 of the needle 101 when the user releases the actuator assembly 125(return stroke or out stroke of the actuator). With the needle 101 nowgripped by the second gripping mechanism 210, the user can depress theactuator 125 (a second inward stroke) in order to actively extract theneedle 101 from the tissue 10 as seen in FIG. 1e . Finally, in FIG. 1fthe user releases the actuator 125 (a second return stroke or outstroke) and the needle 101 is rotated back to its origin, allowing theuser to repeat the suture delivery process. The user may also activatethe integral suture cutter (not shown) to cut the suture 102 to lengthor to trim the knotted suture.

In a preferred embodiment the device 100 is provided sterile inpackaging, such as a blister pack. The device 100 comes out of thepackage in an at-rest condition where the needle 101 is gripped by thefirst gripping mechanism 200 near the distal end of the device 100, andthe second gripping mechanism 210 is in its at-rest position enclosingthe distal end of the needle 103, but not gripping the needle 101. Theneedle 101 features a length of suture from its mid-section.

The device 100 is constructed such that the actuator assembly 125 isoperatively connected to a mechanism (linkage) that translates themovement of the actuator assembly 125 into controlled movement of thefirst and second gripping mechanisms 200, 210 in the manner describedwith reference to FIGS. 1a -1 f.

FIG. 1g shows device 100 according to one embodiment. FIGS. 2 and 3 showinner components and mechanisms that serve to controllably move thefirst and second gripping mechanisms 200, 210 in response to operationof the actuator assembly 125.

In one embodiment, the actuator 125 protrudes from the side of thehousing 110 and swings (pivots) in an arcing motion from a first at-restposition to a mechanically limited, end-of-travel second positionpartially or fully inside or outside of the housing when squeezed by theuser (i.e., an inward stroke of the actuator). A return spring 130biases the actuator 125 toward the at-rest position and offersresistance to the user when squeezing. The return spring 130 is disposedwithin the hollow interior of the handle body. For example, the returnspring 130 can be in the form of an elongated spring that has one endcoupled to a first structure, such as the handle and an opposite endthat is coupled to the actuator assembly 125. The return spring 130 isconfigured such that when an inwardly directed force is applied to theactuator body to cause the actuator body to pivot, the return spring 130stores energy. After reaching the end of the inward stroke of theactuator, the energy stored in the return spring 130 is released and theactuator undergoes an outstroke movement and returns to the initial restposition.

The actuator (assembly) 125 is connected to the second grippingmechanism 210 by mechanical means (gears, linkages, belts, cables orother means known to the art) such that when the actuator 125 moves fromits at-rest position to its fully depressed position, the secondgripping means 210 moves proportionally from its at-rest position to itsfully retracted position. In this embodiment, the gear train connectingthe actuator 125 and the second gripping mechanism 210 has approximatelyan 8:1 ratio; ˜20 degree rotation of the actuator 125 results in a ˜160degree rotation of the second gripping mechanism 210. Of course,alternative gear count, size and ratios could be employed to accomplishthe dynamic relationship between the actuator and second gripping means.In the at-rest position, the second gripping mechanism 210 can bethought of as being in a 6 o'clock position and in the fully retractedposition, the second gripping mechanism 210 can be thought of as beingin an approximately 1 o'clock position.

As shown in FIG. 10, the actuator 125 can be fixedly connected to afirst gear (fan gear) 350 which moves in unison with the actuator 125(and can be formed as an integral part thereof). The first gear 350 thuspivots about pivot 129 and includes teeth that face the second end 113of the housing 110. The teeth of the first gear 350 mesh with a firstset of teeth that belong to a second gear 360 that is pivotally mountedto the housing 110 and spaced from the actuator body 126. The secondgear 360 also includes a second set of teeth that face the second end(distal end) 113 of the housing 110. The second gear 360 can be in theform of a reducer gear that can accomplish the approximately 8:1 ratiomentioned above. The second set of teeth of the reducer gear 360 meshwith teeth of a third gear 370 which pivots about an axle 390. The thirdgear 370 is fixedly coupled to the movable second gripping mechanism 210and therefore, rotation of the third gear 370 results in rotation of thesecond gripping mechanism 210 and in this manner, the second grippingmechanism 210 can move across the range of motion shown in FIGS. 1a -f.

It will be appreciated that one function of the actuator 125 is to movethe second gripping mechanism 210 in a pivoting manner. In both theinward stroke and the out stroke of the actuator 125, the motion of theactuator 125 is directly translated into pivoting of the second grippingmechanism 210 due to the action of gears 350, 360, 370 (which can beconsidered a linkage that operatively connects the actuator with thesecond gripping mechanism).

A second function of the actuator 125 will now be described an inparticular, this second function deals with the alternating opening andclosing of the first and second gripping mechanisms 200, 210 tofacilitate the transfer of the needle 101 between the two mechanisms200, 210 as a result of an energy transfer mechanism. In other words,the states (open or closed) of the first and second gripping mechanisms200, 210 are altered by action of the actuator 125.

The actuator 125 is also connected (by gears or other means) to anenergy storage device (member) 140. In one embodiment, this energystorage device 140 is a torsion spring 141.

It will be appreciated that the device 100 can utilize other mechanismsinstead of the torsion spring 141 shown in the figures so long as thesemechanisms provide the desired movements as described herein. Forexample, other embodiments can incorporate and be based on other kindsof springs, air compressing pistons, fly wheels, opposing magnets or anyother energy storage means known to the art.

The torsion spring 141 is an elongated structure that has a first end142 and an opposite second 144. Like the return spring 130, the torsionspring 141 is disposed within the hollow interior of the handle body andas shown, the return spring 130 and the torsion spring 141 can bedisposed parallel to one another. The two springs 130, 141 can belocated substantially side-by-side and they can partially overlap oneanother.

The torsion spring 141 can be coupled to a first mount (cap) (connector)150 that is located at the first end 142 of the torsion spring 141 and asecond mount (connector) 160 that is located at the second end of thetorsion spring 141. The mount 150 is a fixed structure in that it doesnot rotate and serves as means for fixing the first end of the torsionspring 141 to the surrounding structure. Conversely, the second mount160 moves with the torsion spring 141 and thus, both the torsion spring141 and the second mount 160 are free to rotate in a first direction asthe torsion spring stores energy and both are free to rotate in a seconddirection as the torsion spring 141 releases energy. As a result, whenthe second mount 160 is driven (rotated), as described below, thetorsion spring 141 is likewise driven (rotated) in the same direction.Conversely, when the stored energy is released and the torsion spring141 rotates and unwinds, the second mount 160 likewise rotates in thesame direction.

The second mount 160 can thus be in the form of a circumferentialstructure that can be disposed about the second end of the torsionspring 141.

The internal energy transfer mechanism also includes a pinion gear 170which is fixedly connected to the torsion spring 141 by means of thesecond mount 160. The pinion gear 170 is thus coupled to the secondmount 160 such that the two parts move in unison. For example, rotationof the pinion gear 170 is translated into rotation of the second mount160. The pinion gear 170 is driven by a rack 180 that is coupled to (butseparate from) the actuator body 126 such that the actuator body 126 andrack 180 move together. The rack always remains coupled to the piniongear 170. As shown in FIG. 3, both the rack 180 and the actuator body126 can pivot (rotate) about a pivot point 129. On the inward stroke,the actuator 125 contacts and pushes the rack 180. A partial stroke andrelease causes the rack 180 to rotate the pinion 170 but then reversedue to the torsion spring 141. In a full inward stroke, the rack 180remains with the pinion gear 170 when the pawl (described herein) lockthe windup mechanism (described herein) in a cocked position. The returnspring 130 alone creates the outstroke of the actuator 125. Since therack 180 is not directly connected to the actuator body 126, the rack180 stays in place in the cocked position during the out stroke of theactuator 125 until the stored energy of the windup mechanism is releasedat which time, the rack 180 returns to its first (initial) position.

The rack 180 includes an elongated arm portion 182 that is connected tothe pivot point 129 and an engagement portion 184 which contains teeththat intimately mesh with the teeth of the pinion gear 170. As a result,when the rack 180 pivots about the pivot point 129, the engagementportion 184 moves in a sweeping action and this motion is directlytranslated into rotation of the pinion gear 170. This rotation of thepinion gear 170 is translated into rotation of the torsion spring 141and depending upon the direction that the pinion gear 170 is rotated,the torsion spring 141 will either windup and store energy or wind-downand release stored energy. In particular, the pinion gear 170 iswound-up one half turn by the rack 180 when the actuator 125 isdepressed fully (a full inward stroke of the actuator), and isconfigured to hold the stored energy of this half turn when the actuator125 reaches its fully depressed position.

It will be appreciated that the rack 180 alternatively can be arc shapedand not have an L-shape as shown provided that the rack 180 issupported. In addition, the rack 180 also does not have to share a pivotwith the actuator 125.

Looking at FIGS. 2-5, the energy transfer mechanism also includes awindup ratchet 190 that is a generally hollow body that includes a firstend 192 and an opposite second end 194, with the first end 192 facingthe pinion gear 170. As described herein, the windup ratchet 190 isdisposed within the housing 110 in such a way that it has controlledrotation therein during the inward stroke and a subsequent out stroke.As used herein, the “windup mechanism” comprises the torsion spring 141,the mounts 150, 160, the pinion 170 and the windup ratchet 190.

The windup ratchet 190 includes a first window (opening) 191 and asecond window (opening) that is spaced from the first window 191. Thefirst and second windows 191 can be formed about 180 degrees from oneanother. The windup ratchet 190 includes at least one protrusion 195that extends outwardly from the outer surface of the windup ratchet 190.As shown in FIG. 4, each protrusion (tab) 195 can be located adjacentone of the windows.

In one embodiment, as described herein, the protrusion 195 acts asmechanism for restricting movement (rotation) of the windup ratchet inone direction. More specifically, the housing 110 can include aninterference (a wall) that stops and limits the rotation of the windupratchet 190 when the protrusion 195 makes contact (seats against) suchwall or other part. The windup ratchet 190 is configured to rotate 180degrees and thus, the protrusion 195 and interference are formed suchthat the windup ratchet 190 is prevented from being rotated more than180 degrees. As described herein, other alternative 180 degreemechanisms can be incorporated into the device including element 163which is discussed herein. In particular, a stop can be incorporatedinto any one of the components that make up the windup mechanism tolimit its travel to 180 degrees (the actuator stroke distance limits theinstroke rotation angle of the windup assembly and the protrusion 163limits the rotation angle of the windup assembly during the outstroke).

It will be understood that the cap 160, the pinion gear 170 and thewindup ratchet 190 can be formed as single part as opposed to threeseparate parts.

In one embodiment, the fixed coupling between the windup ratchet 190 andthe pinion gear 170 allows the windup ratchet 190 to rotate 180 degreesas the rack 180 is moved by operation of the actuator 125. As justmentioned, the protrusion 195 on the windup ratchet 190 engage thehousing 110 in order to limit the rotation of the windup ratchet 190 to180 degrees of movement. This stop (e.g., protrusion 195) serves to stopthe windup mechanism after the energy in the windup mechanism isreleased. As described herein, a pawl 220 additionally controls therotation and timing of the rotation of the windup ratchet 190. Thestop/interference point can be thought of as being a zero point of thepinion rotation and the pawl engagement (described herein) is the 180degree point.

In addition, the windup ratchet 190 also rotationally engages acrankshaft ratchet 230. The crankshaft ratchet 230 is fixedly attachedto an elongate crankshaft 240. Similar to the windup ratchet 190, thecrankshaft ratchet 230 is a hollow structure that includes a first end232 and an opposite second end 234. As shown in the figures, thecrankshaft ratchet 230 is disposed along the length of the crankshaft240 such that a first portion of the crankshaft 240 extends outwardlyfrom the first end 232 and a second portion of the crankshaft 240extends outwardly from the second end 234.

As shown in the figures, the crankshaft ratchet 230 includes a first endportion 280, a second end portion 285 and a center portion 290 that islocated between the first and second end portions 280, 285. Each of thefirst end portion 280, second end portion 285, and center portion 290thus extends circumferentially about the crankshaft 240. The first endportion 280 faces the pinion gear, while the second end portion facesthe gripping mechanisms 200, 210. The first end portion 280 has a pairof first flexible tabs 231 that can be in the form of flexible fingersthat each has a beveled free end. The flexible tabs 231 can be orientedapproximately 180 degrees apart. The second end portion 285 can be amirror image of the first end portion 280 and includes a pair of secondflexible tabs 233 that can be in the form of flexible fingers that eachhas a beveled free end.

The center portion 290 includes a pair of locking tabs 291 that areoriented approximately 180 degrees apart from one another. The lockingtabs 291 have a beveled appearance that terminates in a locking surface293. The locking tabs 291 face in opposite directions in that thelocking surface 293 of one locking tab 291 faces in one direction, whilethe locking surface 293 of the other locking tab 291 face in an oppositedirection as shown.

The first flexible tabs 231 are configured to selectively engage thefirst and second windows formed in the windup ratchet 190 to selectivelyinterlock the crankshaft ratchet 230 to the windup ratchet 190 duringoperation of the actuator cycle(s). As described herein, when thecrankshaft ratchet 230 is coupled to (interlocked with) the windupratchet 190, the rotation of the windup ratchet 190 is translated to thecrankshaft ratchet 230 and since the crankshaft 240 is attached to thecrankshaft ratchet 230, the crankshaft 240 itself rotates in unison withthe other coupled parts. As described herein, the rotation of thecrankshaft 240 controls the operation of one aspect of the first andsecond gripping mechanisms 200, 210 to allow for the shuttle action ofthe needle 101 between the two gripping mechanisms 200, 210.

In the initial position of the device, the flexible tabs 231 aredisposed within windows 191 of the windup ratchet 190. During a firstinward stroke of the actuator 125, the windup ratchet 190 is rotated ina first direction by the motion of the actuator 125 as described hereinand this results, in the windows 191 of the windup ratchet 190 movingrelative to the first flexible tabs 231 of the crankshaft ratchet 230(which remains fixed and stationary during the inward stroke due to astop formed as part thereof (e.g., tab 233)). As the windup ratchet 190rotates, the tabs 231 flex and are disengaged from the respectivewindows 191 due to the cam surfaces (structures) of the tabs 231. At theend of the first inward stroke, the tabs 231 are placed in registrationwith windows 191 (i.e., the opposite windows compared to the startingpoint) of the windup ratchet 190 and the compressed tabs 231 spring intothe windows 191, thereby releasably interlocking the two ratchets 190 toone another (See FIG. 5).

As described below, the pawl 220 is unlatched during the initial restposition of the device and becomes latched during an inward stroke andthis prevents the entire now linked assembly from moving (rotating). Inaddition, as shown in FIG. 8, during the inward stroke of the actuator125, the tabs 233 serve as an anti-reverse feature that preventsrotation of the crankshaft ratchet 230 during the inward stroke of theactuator 125. This results when the tabs 233 contact a stop 169 that ispart of the housing 110 as shown in FIG. 8.

When the actuator 125 is released and the actuator 125 undergoes its outstroke action, the actuator 125 is returned to its initial rest positionby means of the return spring 130. During almost the entire outstrokeaction, the releasably coupled windup ratchet 190 and crankshaft ratchet230 do not move (due to the stops (i.e., tabs 233) and other featuresdescribed herein) until the pawl 220 is tripped as described herein atwhich time the windup mechanism becomes released from the pawl 220 andspins (rotates) 180 degrees in the opposite second direction due to therelease of the stored energy of the torsion spring 141. It will beunderstood and is described herein that during the out stroke, themovable second gripping mechanism 210 moves.

When the user performs the next second inward stroke action of theactuator 125, the process repeats and the tabs 231 are released from thewindows 191 due to the rotation of the windup ratchet 190 and thestructure (cam edge) of the tabs 231. The process repeats and the windupmechanism stores energy and the windup ratchet 190 rotates about 180degrees before tabs 231 reengages windows 191, thereby fixedly (yetreleasably) coupling the windup ratchet 190 to the crankshaft ratchet230 as described above.

As best shown in FIGS. 6-7, the pawl 220 is disposed within the housing110 and has a degree of movement within the housing 110. Moreparticularly, the pawl 220 pivots about a pivot 223 as shown in FIG. 8.The pivot 223 is located at a first end of the pawl 220. The pawl 220 isbiased by a biasing member 221, such as a spring, that applies a biasingforce to the pawl 220. The spring 221 can be oriented horizontal orvertical and biases the pawl 220 into the crankshaft ratchet 230 formaintaining the crankshaft ratchet 230 and crankshaft 240 in a heldposition (no rotation) (See FIG. 7).

The pawl 220 also includes a trip lever 224 that is in the form of aprotrusion that extends outwardly from the pawl 220 at a second endopposite the first end. The trip lever 224 can have a rounded shape asshown. The pawl 220 also includes a step or locking member 227 that hasa locking surface (a shoulder) 228 that is configured to selectivelyengage one of the locking tabs 291 formed in the center portion 290 ofthe crankshaft ratchet 230. More particularly, the step 227 serves tohold the windup mechanism in a cocked position. This windup mechanismand the crankshaft components can be thought of as being a linkage thatoperatively couples the actuator to the first and second grippingmechanisms for controllably moving each of the gripping mechanismbetween open and closed positions. As described herein, this cockedposition is maintained until the trip lever 224 of the pawl 220 isactuated (tripped) by coming into contact with a trigger which in thecase of the illustrated embodiment is a wall that is part of theactuator 125 of the suturing device 100. In particular, the actuator 125includes a recess 260 formed therein. One end of the recess 260 isdefined by a wall (ledge) 261 which acts as a trip for the pawl 220. Asunderstood, the actuator 125 is pivoting and thus the recess 260 and thewall 261 are continuously moving during an inward stroke and an outstroke of the actuator 125. At the same time, the pawl 220 is pivotallymounted to the housing and the trip lever 224 is disposed within therecess 260. Thus, during the out stroke of the actuator 125, when thetrip lever 224 contacts the ledge 261, the pawl 220 pivots about pivot223, thereby causing the locking member 227 to disengage from thelocking tab 291 of the crankshaft ratchet 230. In particular, up untilthe final stage of the out stroke (e.g., during approximately the last5% of movement of the actuator 125), the pawl 125 is engaged to thecrankshaft ratchet 230; however, during this final stage, the pawl 220is tripped as described herein and the pawl 220 disengages from thecrankshaft ratchet 230, thereby allowing the crankshaft ratchet 230 torotate as the stored energy is released.

Since the pawl 220 is functioning to hold the crankshaft ratchet 230 inits wound up (ready to fire) position, once the pawl 220 is releasedfrom the crankshaft ratchet 230, the crankshaft ratchet 230 releases itsstored energy by rotating over a defined degree of travel (e.g., about180 degrees). As will be understood, the crankshaft ratchet 230 rotatesdue to the release of energy stored by the torsion spring 141 since thecrankshaft ratchet 230 is coupled thereto by its engagement with thewindup ratchet 190 (due to flexible tabs 231 being disposed in thewindows 191). When the windup mechanism is fired and releases itsenergy, the anti-reverse tabs 233 flex to allow rotation of thecrankshaft ratchet 230 as will be appreciated in view of FIG. 8. Morespecifically, in FIG. 8, the crankshaft ratchet 230 rotates in thesecond direction (e.g., counterclockwise in FIG. 8) when the pawl 220 istripped and the mechanism is fired and the cam structure and flexingproperties of the tab 233 allows for such rotation in this seconddirection for the controlled 180 degrees. Conversely, during the inwardstroke, movement of the crankshaft ratchet 230 in the first direction(e.g., clockwise direction in FIG. 8) is restricted by the anti-reversetab 233 contacting the stop 169 of the housing 110. After the firing ofthe windup mechanism, the tab 233 in FIG. 8 that is shown being free ofthe stop 169 then assumes an engaged state with the stop 169.

In one rotational direction (actuator depressing action in theillustrated embodiment), the windup ratchet 190 slips past thecrankshaft ratchet 230, whereas in the opposite rotational direction,the windup ratchet 190 engages and rotates the crankshaft ratchet 230during its rotation (near the end of the actuator return stroke in theillustrated embodiment). This one way clutch, comprised of the windupratchet 190, crankshaft ratchet 230 and pawl 220, is configured withsynchronous, compliant and non-compliant protrusions and grooves, whichcontrol the rotation and timing of these components and the energystorage/release mechanism as described herein. For those skilled in theart, it is understood that many forms of one-way clutches (rotors, pads,drums, diaphragm springs, pressure plates, hydraulic, centrifugal,electromagnetic, etc.) can be used to store and release energy in thisor a similar design.

A rotatable, concentric bearing 250 is affixed to a distal, eccentricportion of the crankshaft 240 and engages the first and second grippingmechanisms 200, 210 in order to create two synchronous clamping states(needle grip and needle release) as the crankshaft 240 rotates in 180degree increments. By mounting the bearing 250 in an eccentric manner,the bearing 250, as it rotates, can contact one of the first and secondgripping mechanisms 200, 210 and then as the bearing 250 continues torotate, it contacts the other of the first and second grippingmechanisms 200, 210 (in an alternative embodiment, the bearing 250 couldbe designed to contact both mechanism 200, 210 at once in adisproportionate manner in that during the 0 and 180 degree states ofthe device, the load can be distributed disproportionately (e.g. 99/1)between the two mechanism 200, 210. As will be described below, thecontact and motion of the bearing 250 against a portion of each of thefirst and second gripping mechanisms 200, 210 causes the respectivegripping mechanism to move between a first clamping state (needle gripstate) and a second clamping state (needle release state).

Eccentricity of the crankshaft 240 can be achieved with a concentricbearing and eccentric shaft or a concentric shaft and eccentric bearing,a single component featuring a shaft and bearing surface, a rotatable orfixed bearing, a bearing that is round or flat-edged, or any otherobvious cammed shaft components and designs. In an alternativeembodiment, there could be multiple bearings acting upon the respectivegripping mechanisms 200, 210 instead of one central bearing (i.e., theconcentric bearing 250). Also, staged bearings that work in tandem tofirst move the bearing 250 and gripping mechanisms 200, 210 nearly intoits final position and then to use additional bearings to move thegripping mechanisms 200, 210 into its final position can be employed.

The device 100 also can include a mechanism to limit (restrict) therotation of the crankshaft 240 to 180 degrees (to keep the crankshaft inphase) during one actuator cycle of the actuator (similar to the othermechanisms described herein to limit rotation of the active parts toabout 180 degrees during one actuator stroke). One type of mechanism isshown in FIGS. 2 and 9 and comprises an inertia wheel assembly 300 isconnected to the crankshaft 240 for the assistive purpose of limitingthe crankshaft's rotation to 180 degrees. The assembly 300 in thisembodiment is generally comprised of a disc 310, a pin 320, and abiasing member 330 (spring, elastic, resilient foam). In its simplestform, the inertia wheel disc 310 is rigidly attached to the crankshaft240 and the pin 320 is biased by the biasing member 330 in retracted(at-rest) position. When the crankshaft 240 rotates rapidly, e.g., asthe stored windup energy is released as described herein, thecentrifugal force exacted onto the pin 320 causes the pin 320 to projectbeyond an outer surface of the disc 310 and to contact the housing 110at one of two locations, which are separated by 180 degrees of rotation.This interference between the extended pin 320 and the housing 110 actsas a stop to limit the degree of travel of the crankshaft 240. The pin320 then retracts when the inertia wheel (disc) 310 stops rotating.

FIG. 4 also illustrates that the part 160 can also include a pin 163(e.g., a spring mount pin) that acts as a hard stop for the windupmechanism after the windup mechanism is tripped (i.e., by disengagementof trip lever 224 of pawl 220). The pin 163 contacts the housing 110 andacts as stop for the windup mechanism (as an alternative to the use oftab 195). It will thus be understood that while FIG. 4 shows both tabs195 and pin or protrusion 163, in practice, only one of these featureswould be provided.

As mentioned, the crankshaft ratchet 230 also engages pawl 220, whichretains the ratchets 190, 230 in an energy stored state and then islater tripped by a feature (i.e., ledge 261 that is part of recess 260formed in the actuator 125—see FIG. 2) when the actuator 125 nears thecompletion of its return stroke (out stroke). It will be appreciatedthat other features in the actuator, gripping means, housing, or otherappropriate element may be used to trip the pawl. This tripping actionof the pawl 220 (during the final stage of the outstroke of theactuator) releases the stored energy in the torsion spring 141, whichinstantaneously rotates the windup ratchet 190, crankshaft ratchet 230,crankshaft 240, and bearing 250 180 degrees as a result of the couplingbetween these parts, as described herein, and this rotation of thebearing 250 activates one of the first and second gripping mechanisms200, 210, while deactivating the other of the first and second grippingmechanisms 200, 210. This action effectively holds the needle 101rigidly in one of the first and second gripping mechanisms 200, 210,while the other of the first and second gripping mechanisms 200, 210releases the needle 101, thus, enabling the transfer of the needlebetween the first and second gripping mechanisms 200, 210.

As mentioned, there are two similar gripping mechanisms (first andsecond needle grippers) 200, 210 in the illustrated embodiment that gripthe needle 101 in essentially the same manner. Each of the grippingmechanisms 200, 210 can be comprised of a stationary (fixed) gripper(jaw) 400, a movable gripper (jaw) 410, and a hinge pin 420 thatpivotally couples the movable jaw 410 to the fixed jaw 400 and allowsthe movable jaw 410 to pivot about point 411. As shown in FIGS. 12 and13, the movable jaw 410 can function as a lever in that when a force isapplied to one end of the movable gripper 410, the other end of themovable jaw 410 pivots about point 411 allowing the needle gripper 200,210 to close. The movable jaw (lever or pin) 410 is contacted by thebearing 250 and rotation of the bearing 250 selectively applies a forceto the movable jaw 410 (such as pressing down on one end of the lever)resulting in movement of the movable jaw 410. In the illustratedembodiment, the bearing 250 contacts a boss 435 that is part of themovable jaw 410 and the rotation of the bearing 250 (as a result of thecrankshaft 240 being driven) results in the jaw 410 being pushed down atone end causing the opposite end to pivot about pivot 411.

As shown in FIGS. 12 and 13, the static (fixed) jaw 400 can be a curvedstructure such that a distal section thereof is elevated relative to theproximal section. The static jaw 400 can have an opening formed thereinthrough which the movable jaw 410 passes. The movable jaw 410 is also acurved structure in that a proximal portion lies within a recess formedin the static jaw 400 and a distal portion passes through the window inthe jaw 400. The distal end of the jaw 400 lies above the distal end ofthe jaw 410 and represents a top portion of the needle receiving groovewhile the distal end of the jaw 410 represents the bottom portion of thegroove.

FIG. 14 shows an alternative gripper design. In this design, there is anelement 430 that lies within a recess of the fixed jaw 400. The movablejaw 410 is pivotally attached to jaw 400 at pivot 411. In thisconstruction, the element 430 selectively applies a force to the movablegripper 410 to cause a pivoting motion. The element 430 is in the formof a lever or pin that is contacted by the bearing 250 and rotation ofthe bearing 250 selectively applied a force to the lever 430 (such aspressing down on one end of the lever) resulting in the lever 430 movinga cam surface 431 at a distal end of the lever 430 contacting the movingjaw 410 to cause pivoting thereof. In the illustrated embodiment, thebearing 250 contacts a boss that is part of the element 430 and therotation of the bearing 250 (as a result of the crankshaft 240 beingdriven) results in the element 430 being pushed down at one end causingthe opposite end to contact and move the movable gripper 410.

This exemplary design has the advantage of a rigid wedging element(lever 430) preventing the separation of the jaws 400, 410 andconsequently the release of the needle. Many alternative wedge-basedlocking/unlocking concepts can easily be recognized, however.

In one embodiment shown in FIG. 13, each gripping mechanism 200, 210 canbe a biased mechanism in that the gripping mechanism 200, 210 can bebiased to assume one position as a result of the applied biasing force.More specifically, the lever 430 or the movable jaw 410 can be biased(as by being coupled to a biasing element 455, such as a spring or thelike as shown in FIG. 13. The bias force applied to the lever 430 ormovable jaw 410 causes the movable gripper 410 to assume an openposition in its normal state. In FIG. 13, the spring 455 is disposedbetween the movable gripper 410 and the static (fixed) gripper 400 atthe proximal end thereof.

The grippers 400, 410 can thus open and close in a pliers-like fashionthat is activated and deactivated by the dual-state eccentric bearing250. As described herein, the movable gripper 410 pivots about the hingepin 420 between open (unclamped) and closed (clamped) positions.

As mentioned, the active (grip) condition and the default (release)condition are energized by the rotating crankshaft 240 and bearing 250when this bearing 250 is at its high point and low point, respectively.In the current embodiment, the gripping force on the needle 101 can bealtered by changing the diameter or degree of eccentricity of thebearing 250, which changes the displacement of the movable gripper 410.The gripping force can also be varied by modifying the distancerelationship between the length of the lever arm of the movable gripper410 and the length from the hinge pin 420 to the gripping means needlegroove 405. In this embodiment, the lever arm enables the device toamplify the load input into the gripping system at a 3:1 ratio, althoughit is easy to recognize that higher or lower ratios can be utilized inorder to provide a gripping force performance similar to a standardneedle driver. Furthermore, the surface of the needle groove 405 can bealtered with notches, ribs, detents, roughness, or similar modificationsin order to enhance the gripping force on the needle 101 and to preventthe needle from pitching, rolling or pulling-out of the gripping means.

It will be appreciated that the cross-sectional geometry of the groove405 in the gripping means provides an effective gripping interfacebetween the two at the location at which the two are in intimatecontact. For example, the interface can be defined as a V-shaped notch,trapezoidal shape, or other geometry thereby creating a matched orcompatible fit between the needle and the gripping means. It will beappreciated that the shapes of the notch and needle can be different,i.e., round, oval, hexagonal, so long as preferably there is theabove-described match fit between the two resulting in an effectiveneedle gripping location. Further, the cross-sections of the needle andthe receiving groove can be different from each other so as they achieveconsistent alignment and sufficient gripping force.

There are two (first and second) safety guards 600, 610 depicted inFIGS. 11 and 15-18 that are located at the distal end of the device 100and protect the user from the sharp point 103 of the needle 100. In theillustrated embodiment the safety guards 600, 610 pivot on a shared axis605, which is also the axis of rotation of the needle 101 and the axisabout which the handle 110 pivots (rotates). The guards are biased toeach other and to the housing 110 by torsion springs 615, although leafsprings, molded-in plastic springs, elastomers, and the like can createsuitable biasing means. In the current device, the first safety guard600 is biased to the housing 110 and shields the needle point when thedevice 100 is in its at-rest position or when the second gripping meansis retracted. Moreover, the second safety guard 610 is biased to thefirst safety guard 600 and shields the needle 101 from the user when theneedle point 103 exits the tissue 10. The biased connections of the twosafety guards 600, 610 enable the first safety guard 600 to rotate inconcert with the device 100 as the user rotates the device into andthrough the tissue 10 and the second safety guard 610 to follow thefirst.

If the user reverses the rotational insertion of the needle, the biasingmeans (springs 615) returns the safety guards 600, 610 to their originalpositions. The bias between the safety guards 600, 610 also allows themto flexibly and reversibly extend away from each other and contourthemselves to the tissue being sutured. This can be particularly usefulwhen the tissue is not flat. The second safety guard 610 is positionedaway from the needle point 103 when the device 100 is at-rest, however,is seated on the tissue, and therefore protecting the user from theneedle point when the needle 101 emerges from the tissue 10. In additionto protecting the user from the needle point, the second safety guard610 also visually identifies the tissue exit location of the needle 101.In the current embodiment, the second safety guard 610 is comprised of astrut 612 that is physically aligned with the needle plane and providesvisual location feedback to the user. It will be understood that otherlocation identifiers alignment features such as cross-hairs, rings,slots, markings and the like can be utilized in order to achieve thesame end. The strut of each safety guard 600, 607 thus provides analignment feature to the user since the user understands that the needle101 will pass just inside the strut. For example, if the needle is beingadvanced through the tissue and is not visible, the user knows, it willpass just inside the strut of the safety guard resting on the tissue asit exits.

The safety guards 600, 610 are merely exemplary and the guards can takeany number of different forms so long as they perform the intendedfunction. For example, the guards can be cage-like as disclosed incommonly owned U.S. patent application Ser. No. 13/584,536, which ishereby incorporated by reference in its entirety, or constructed from aframe-work of formed wire or plastic and can be formed of one or morecomponents and its rotation may be constrained by a spring or othersuitable means as shown. Further, the spring element may be integral tothe framework, e.g., a wire form constructed of spring tempered steel ornickel titanium alloy which possess substantial elasticity. It featuresa spring bias that predisposes the shield towards covering the needlepoint when the device is in its ready to penetrate configuration. Asshown in FIG. 18, a tissue contacting surface of each strut of thesuture guards 600, 610 can include a modified surface (front and/orbottom surface of strut) 609 that enhances gripping/interference betweenthe guard and the tissue (or other object, like a catheter) so that theguard rotates away from the needle point and positions second guard atthe needle exit site. The modified surface 609 can be 3-D structures(barbs, dots, etc.) or can be rough surface or other texture thatpromotes enhanced gripping with tissue (skin).

Finally, a suture cutter 700 that is integral to the handle wouldprovide the user with a means to cut and trim suture 20 during theprocedure. The cutter 700 is an internal dynamic shearing apparatus,i.e., scissors or slideable blade(s) that would require the user topress or slide a button 710 in order to activate a blade 720 to cut thesuture 20. The button 710 directly or indirectly translates the blade720 across the suture 20 and into a slot that is functionally narrow,providing a holding surface for the suture and allowing only the bladeto travel therethrough. This means could be a slideable track if thebutton 710 were to slide in the direction of the blade 720, or a pair ofmatched ramps that would convert the vertical motion of the depressedbutton 710 to a horizontal motion of a cutting blade 720. Further theblade 720 may act in a pivoting manner that slices across the suture 20.A spring or other suitable means 730 returns the button 710 to itsoriginal position. Further, the suture 20 is positioned in a notch 740(dog-legged, slot, or hole) on the outer surface of the housing 110 inorder for the user to cut it to a predetermined or greater length.

In this preferred embodiment, the position of the cutter blade 720relative to the surface of the housing 110 determines the length of thecut suture tail. Also, the cutter blade angle directs the suture 20 intothe terminus of the dog legged slot 740 in order to optimize the cuttingaction.

In use of the preferred embodiment device, the user removes the device100 from its sterile packaging in its at rest position with the needletip enclosed by the second gripping mechanism 210 and the proximal endof the needle gripped by the first gripping mechanism 200. The user thengrips the device 100. In a preferred embodiment, the user grips thedevice 100 between his/her thumb and one or more fingers with the user'sthumb on the actuator 125.

The user then depresses the actuator 125, retracting the second grippingmechanism 210, exposing the needle tip 103, and winding-up the energystorage mechanism.

The user then positions the needle tip 103 against the tissue 10 to besutured and passes the needle tip 103 through the tissue 10 by rotatingthe housing 110 in an arcing motion until the needle tip 103 emergesfrom the tissue 10. The second safety guard 610 surrounds or shields theneedle point 103 from the user.

Next, the user slightly and controllably releases his grip on theactuator 125, allowing the return spring 130 to move the actuator 125into its initial at-rest position, and, in so doing, rotates the secondgripping mechanism 210 to re-engage the distal tip 103 of the needle101. When the actuator 125 reaches the end of its stroke at the at-restposition, the pawl 220 releases the wound-up torsion spring energy inthe energy storage mechanism, causing the crankshaft 240 and bearing 250to rotate one half turn (i.e., 180 degrees), thereby switching the stateof the gripping mechanisms 200, 210 such that the first grippingmechanism 200 is now released and the second gripping mechanism 210grips the distal end 103 of the needle 101.

Next, the user depresses the actuator 125. The second gripping mechanism210, now gripping the needle 101, rotates from the at-rest position tothe retracted position, and in so doing, actively and rotationallyextracts the needle 101 from the tissue 10. This actuator movement alsowinds-up the energy storage mechanism for its next action.

Still depressing the actuator 125, the user lifts the device 100 fromthe tissue, pulling a length of suture 20 through the tissue 10. Theuser then releases his/her grip on the actuator 125, allowing it torotate back to the at-rest position, and in so doing rotating the secondgripping mechanism 210 to its at rest position, releasing the storedspring energy in the energy storage mechanism, rotating the crankshaftand bearing, and switching the state of the gripping mechanisms 200, 210to its original condition where the first gripping mechanism 200 gripsthe proximal end 103 of the needle 101 and the second gripping mechanism210 has released the needle 101, yet still covers the needle point 103.

Finally the user ties the suture 20 to form a stitch and trims thesuture near the knot, leaving the user holding the device 100 in exactlythe same condition as when it was removed from the package, except for aslightly shorter length of suture. The device 100 is now ready todeliver additional sutures.

Now referring to FIGS. 19-26 in which alternative first and secondneedle grippers 800, 810 are shown. As with the previous embodimentsdisclosed herein, the first and second needle grippers 800, 810 areoperatively coupled to an actuator, such as actuator 125, by means of alinkages (i.e., the first and second linkages described herein) or someother mechanical means (belts, cables or other means known to the art)such that when the actuator moves from its at-rest position to its fullydepressed position, the second needle gripper 810 moves proportionallyfrom its at-rest position to its fully retracted position. In theillustrated embodiment, the actuator assembly comprises actuatorassembly 125 as described herein including the windup mechanism andcrankshaft ratchet assembly, and the pawl 220.

As in the previous embodiment, an energy mechanism serves toreciprocally activate the first and second needle grippers 800, 810 inorder to effect the gripping, releasing, and the transferring of theneedle 101. When one of the first and second needle grippers 800, 810 isactivated to grip the needle 101, the other of the first and secondneedle grippers 800, 810 is deactivated and releases the needle 101.

In one embodiment, the connection between the needle gripper andactuator is comprised of a connecting arm 820, threaded nut 822 andthreaded axle 824. In summary, the motion of the connecting arm 820creates the alternate gripping-releasing of the first and second needlegrippers 800, 810 by rotating and translating the threaded nut 822 alongthe stationary threaded axle 824 into and away from the respective firstand second needle grippers 800, 810.

Specifically, the connecting arm 820 is generally axially orientedrelative to the device housing and is connected by a generally rigidmechanical means to the actuator. Further it is pivotably attached tothe threaded nut 822 via a nut pivot 825. The threaded nut 822 featuresan internal thread 826 that intimately surrounds and engages a threadedaxle flight 828 of the threaded axle 824. This axle 824 is heldstationary i.e., non-rotating, via the engagement between a threadedaxle flat 829 and the first needle gripper 800. Note that the flat 829can be another configuration, e.g., square, hexagonal, pinned, and canbe located anywhere along the axle 824 such that it engages the housing110, static clamp or jaw 830 or other component restricting itsrotation. It is this stationary condition of the threaded axle 824 thatallows the threaded nut 822 to rotate about the axle's axis andtranslate toward and press against the moving clamp or jaw 840 of one ofthe first and second needle grippers 800, 810. When the threaded nut 822compresses that respective moving jaw 840 of the moving second needlegripper 810, which is comprised of the moving jaw 840 and static jaw830, the second needle gripper 810 is activated to firmly grip theneedle 101.

Another result of the threaded nut 822 engaging the moving jaw 840 ofthe second needle gripper 810 is that the nut 822 has separatedcompletely from the moving jaw 840 of the non-rotating first needlegripper 800, and in a direct effect has deactivated the grippingcondition of that first needle gripper 800. This opening action of themoving jaw 840 may be aided by a spring or other biasing means thatfacilitates the release of the needle 101 by the first and second needlegrippers 800, 810. This may be advantageous for releasing the needle butalso in biasing the first and second needle grippers 800, 810 such thatit is configured in its open condition to readily accept the needle inthe subsequent transferring phase.

FIG. 27 presents alternative means for activating a threaded nut 850comprising an internal thread 852, and oscillating the nut 850 into andaway from the first and second needle grippers 800, 810. FIG. 27illustrates that threaded nut 850 is simultaneously rotated andtraversed by the axial displacement of a rack 860, which is coupled tothe actuator 125. As the actuator is depressed, the rack 860 movestangentially across the nut 850 and rotates the nut whose threads 852are engaged intimately with the threads 872 of the stationary threadedaxle 870. At the same time the nut 850 is rotating, it is traversinglaterally along the axle threads 872 and towards the first and secondneedle grippers 800, 810 due to the pitch of the threads. This actioncreates the travel and force required to activate and deactivate therespective first and second needle grippers 800, 810 through alternatelycompressing the respective moving jaws 840 of the first and secondneedle grippers 800, 810.

FIG. 28 illustrates another mechanism for activating the first andsecond needle grippers 800, 810 via the threaded nut 850. As in FIG. 27,the nut 850 traverses across the threaded axle 870, however, the rack860 in this mechanism acts upon and rotates the threaded axle 870, andnot the nut 850. This rotation causes the nut 850 to traverse, but notrotate, such that it activates and deactivates the first and secondneedle grippers 800, 810. Rotation of the nut 850 is inhibited by asingle or multiple tabs 875 projecting from the nut and engaging asingle or pair of corresponding grooves in the housing 110 or similarstationary feature. These tabs 875 however are able to slide laterally,freely and guide the nut 850 during its traverse.

Yet another variation for first and second needle grippers 800, 810activation by way of a traversing nut is depicted in FIGS. 29 and 30. Asmentioned, the first and second needle grippers 800, 810 are comprisedof static jaw 830, moving jaw 840 and hinge pin 835. In this embodiment,two springs 880, 882 apply alternating forces to the respective movingjaw 840 in order to grip and release needle 101. More specifically,drive gear 885 is rotated by the movement of actuator 125 and rotatesaxle gear 887, which is rigidly coupled to rotating axle 889. Further,this rotating axle 889 features one or more axle pins 890 that engageand follow the nut's cam surfaces 892, 894 and as a result, translatethe nut 895 toward and away from the first and second needle grippers800, 810. The nut tab(s) 897 engage a rotation stop in static jaw 830 ofthe non-rotating first needle gripper 800 so that the nut 895 does notrotate, but rather translates. FIG. 29 shows a condition in which thenut 895 has translated towards the non-rotating first needle gripper 800and has compressed spring 880 such that spring 880 cannot apply a forceto moving jaw 840, but has allowed spring 882 to elongate and apply itsfull force to the moving jaw 840 of the moving second needle gripper810. In this condition, the first needle gripper 800 has released theneedle 101 and second needle gripper 810 has gripped it. It is throughthis mechanism that the needle 101 is gripped and released by the firstand second needle grippers 800, 810.

Although the actuator 125 has been mentioned as the direct input forceprovider into these systems, please understand that there are multiplemechanisms that may couple the actuator and the nut-driven grippingassemblies. For example, a rotational windup system comprising a torsionor other spring type can store energy and release it in order to rotatethe nut or axle. Further, a linear system comprising a rod, linkage orthe like can be utilized to rotate the nut or axle. And, a hybrid ofrotational and linear mechanisms may also be used to perform thesefunctions. The above examples may further comprise a clutch orratcheting system that holds the stored energy until such time that theuser wishes to cycle the mechanism or a trip feature such as a pawl,lynch pin, or similar automatically cycles the mechanism. These systemsmay also rely on a unidirectional rotation of a crankshaft or axle, or arotation that may oscillate clockwise-counterclockwise. Therefore it iseasily understood that multiple mechanisms can serve to activate anut-driven needle gripping device.

FIG. 31 shows an alternative cutter arrangement. In this embodiment, thecutter mechanism 900 is of a pivotable, non-linear actuated type. Thecutter mechanism 900 includes a cutter body 910 that has a first end 912that is pivotally attached to the housing 110 (at pivot 913) and anopposite second end 914 that is a free end. The cutter body 910 holds ablade 920 that faces inward toward the housing 110. The cutter body 910includes a lip 915. The housing 110 includes a space 917 for receivingthe cutter body 910 in the fully retracted cutting position thereof. Thespace 917 terminates at the proximal end of the housing 110 and includesa catch (lip) 919. The lip 915 is received within the space 917 and whenthe lip 915 contacts the catch 919, the outward movement of the cutterbody 910 is limited since the engagement of lip 915 to catch 919 servesas a stop. A biasing member, such as a spring 930, is disposed withinthe housing 110 and is disposed partially within the space 917. Thespring 930 is shown in a fully extended (rest) position in the figure.An inner surface of the cutter body 910 includes a protrusion 925 facingthe housing 110. The protrusion contacts the spring 930 when the cutterbody 910 is pushed into the space 917 for cutting the suture. The blade930 is received within a blade receiving space 917 of the housing 110and a notch 950 is in communication with the blade receiving space 917.

Based on the foregoing, it will be appreciated that the device 100provides a single actuator that can be used with one hand and allows theuser to complete one actuator cycle by pressing and then releasing thesingle actuator two times. All of this can be done with a single handduring the procedure. In addition, the present device can be providedsuch that the actuator and cutter can be located on the same side of thedevice to allow the user to use the same thumb to operate both.

While the invention has been described with reference to exemplaryembodiments, it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted forelements thereof without departing from the scope of the invention. Inaddition, many modifications may be made to adapt a particular situationor material to the teachings of the invention without departing from theessential scope thereof. Therefore, it is intended that the inventionnot be limited to the particular embodiment disclosed as the best modecontemplated for carrying out this invention, but that the inventionwill include all embodiments falling within the scope of the appendedclaims.

1. A device for suturing tissue comprising: a handle including a housing having a distal end and an opposite proximal end; a suturing needle for advancing a suture through the tissue, the suturing needle having a first pointed end and an opposite second end; a first needle gripper coupled to the housing, the first needle gripper being configured to both grasp and release the suturing needle; a second needle gripper coupled to the housing, the second needle gripper being configured to both grasp and release the suturing needle; and an actuator that is coupled to the housing, the actuator being operatively coupled to: (a) a first linkage that pivots the second gripping gripper between a fully extended position and a retracted position relative to the housing; and (b) a second linkage that is operatively coupled to the first and second needle grippers and configured to alter a state of each of the first and second needle grippers to permit each respective needle gripper to either: (a) receive and grasp the suturing needle or (b) release the suturing needle; wherein the second linkage includes a one-way clutch that is operatively coupled to the actuator and is configured to synchronously alter the states of the first and second needle grippers to permit each respective needle gripper to either: (a) receive and grasp the suturing needle or (b) release the suturing needle.
 2. The device of claim 1, wherein the actuator moves in a sweeping, non-linear motion relative to the housing
 3. The device of claim 1, wherein the first linkage comprises a plurality of gears that operatively couple the actuator to the second needle gripper such that motion of the actuator is translated into the second needle gripper rotating about a first pivot point between the fully extended position and a retracted positions.
 4. The device of claim 3, wherein the first linkage includes a first gear that is associated with the actuator; a second gear that meshes with the first gear; and a third gear that is fixedly coupled to the second needle gripper such that a pivoting movement of the actuator causes the first, second and third gears to rotate resulting in rotation of the second needle gripper.
 5. The device of claim 4, wherein the first gear is a fan gear and the second gear is a reducer gear that is configured such that the second needle gripper rotates a greater number of degrees than the actuator.
 6. The device of claim 1, wherein the second linkage comprises an energy storage mechanism that is configured to store energy during an inward stroke of the actuator and release the stored energy during one stage of an outstroke of the actuator, whereby the release of the stored energy causes the states of the first and second needle grippers to be altered.
 7. The device of claim 6, wherein the one stage of the outstroke comprises a final stage of the outstroke.
 8. The device of claim 6, wherein the energy storage mechanism includes a windup mechanism and a crankshaft assembly whose operation alters the states of the first and second needle grippers, the windup mechanism includes a first spring that stores energy during the inward stroke of the actuator as a result of a coupling between the actuator and the windup mechanism and release the stored energy during the one stage of the outstroke of the actuator, the windup mechanism being configured to selectively engage and interlock with the crankshaft assembly, the crankshaft assembly being maintained in a held position until the one stage of the outstroke at which time the crankshaft assembly is released from the held position and the windup mechanism releases its stored energy resulting in the crankshaft assembly rotating a predetermined number of degrees.
 9. The device of claim 8, wherein the windup mechanism rotates 180 degrees in a first direction during the inward stroke of the actuator and during the one stage of the outstroke, the windup mechanism and the crankshaft assembly rotate 180 degrees in an opposite second direction.
 10. The device of claim 8, wherein the one-way clutching comprises a portion of the windup mechanism, a portion of the crankshaft assembly and a pawl that selectively engages the crankshaft assembly to restrict movement of the windup mechanism and the crankshaft assembly until the one stage of the outstroke.
 11. The device of claim 8, wherein the windup mechanism includes a torsion spring that is fixed to the housing at a first end and has a second end that is fixed to a pinion gear that is coupled to the actuator by a rack that moves when the actuator moves relative to the housing such that movement of the actuator is translated into rotation of the pinion gear and rotation of the windup mechanism, the windup mechanism further including a windup ratchet that is fixedly attached to the pinion gear and rotates therewith.
 12. The device of claim 11, wherein the windup ratchet has a pair of windows formed therein that selectively receive a pair of first flexible tabs that are part of a crankshaft ratchet that is part of the crankshaft assembly to releasably interlock the windup ratchet to the crankshaft ratchet, the pair of windows being formed 180 degrees apart from one another and the pair of first flexible tabs being formed 180 degrees apart from one another, the crankshaft ratchet being fixedly connected to a crankshaft that drives the movements of the first and second needle grippers.
 13. The device of claim 12, wherein the crankshaft ratchet includes an anti-reverse feature to prevent rotation of the crankshaft during the inward stroke of the actuator.
 14. The device of claim 13, wherein the anti-reverse feature comprises a pair of second flexible tabs formed as part of the crankshaft ratchet, wherein the second flexible tabs contact a portion of the housing to prevent rotation of the crankshaft ratchet in one direction when the windup mechanism is being wound during the inward stroke.
 15. The device of claim 12, wherein the crankshaft assembly includes a stop mechanism to restrict rotation of the crankshaft to a predetermined number of degrees when the windup mechanism releases its stored energy.
 16. The device of claim 15, wherein the stop mechanism comprises a body attached to the crankshaft and at least one biased pin slidably disposed within an opening formed in the body such that rotation of the body during the release of energy by the windup mechanism causes the pin to protrude beyond a peripheral edge of the body due to centrifugal force exacted onto the pin and make contact with a fixed stop that is part of the housing resulting in the crankshaft only traveling the predetermined number of degrees when the windup mechanism releases its stored energy.
 17. The device of claim 8, wherein the crankshaft includes an eccentrically mounted bearing that is rotated and applies an alternating force to the first and second needle grippers to change the states of first and second needle grippers in a reciprocal manner.
 18. The device of claim 1, wherein each of the first and second needle grippers comprises a first static clamp and a second movable clamp that is pivotally attached to the first static clamp at a pivot to permit the second movable clamp to pivot between open and closed positions, each of the first static clamp and the second movable clamp defining a needle receiving groove in which the suturing needle is captured.
 19. The device of claim 1, wherein the second movable clamp is biased to the open position.
 20. The device of claim 18, wherein the second linkage includes a part that applies a force to the second movable clamps of the first and second needle grippers in an alternating manner to cause the reciprocal opening and closing of the first and second needle grippers. 21-23. (canceled) 